Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030679
• Other study ID #: 19DM05L
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2009
• Last updated: December 14, 2009
• Start date: July 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2009
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Type ? diabetes mellitus

• Fasting Plasma Glucose(FPG)= 126 and = 270

• HbA1c between 7 and 11%

• Body mass index (BMI) in the range 21-40

• The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month

• Agreement with written informed consent

Exclusion Criteria:

• Type I diabetes, gestational diabetes or secondary diabetes

• Treatment with insulin(over 1month) within 3 months

• Fasting Plasma Glucose level is over 270 mg/dl

• Triglyceride level is 500 mg/dl and over

• Uncontrollable hypertension

• History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months

• Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)

• Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit

• Needs treatment for acute disease, uncontrolled other diseae or diabetic complications

• In treatment concomitant drug having severe risk drug interaction with investigational drug

• History of cancer within 5 years

• History of drug abuse or alcoholism

• Hepatitis B Antigen(HBsAg) test is positive

• Treatment systemic or inhalant corticosteroids within 1 month prior to Screening

• Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones

• Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers

• Has a contraindication to treatment investigational drug from the medical and psychogenic side

• Participated in other trial within 4 weeks Participating in other trial at present

• An impossible one who participates in clinical trial by legal or investigator's decision

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• CKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
• CKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
• CKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
• Placebo
orally, 1 tablet once daily for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Inje University Medical Center	Busan
Korea, Republic of	The Yeungnam University Hospital	Daegu
Korea, Republic of	The Chtholic University of Korea Uijeongbu St. Mary's Hospital	Gyeonggi-do
Korea, Republic of	The Seoul National Univertisy Bundang Hospital	Gyeonggi-do
Korea, Republic of	The Wonju Christian Hospital	Kangwon-Do
Korea, Republic of	The Inje University Sanggye-Paik Hospital	Seoul
Korea, Republic of	The Korea University Anam Hospital	Seoul
Korea, Republic of	The Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in fasting plasma glucose at 8 weeks		8 weeks	No
Secondary	Change from baseline in Glycemic parameters after 8 weeks		8 weeks	No
Secondary	Change from baseline in Lipid parameters after 8 weeks		8 weeks	No
Secondary	Adverse event profile after 8 weeks of treatment		8 weeks	Yes